The present invention relates generally to devices used to collect and filter biological fluid samples for the purpose of preparing the samples to be analyzed and more particularly, but not by way of limitation, to urine collection devices for filtering and fixating cells in the urine in preparation for further analysis.
Urine collection for disease diagnosis is becoming routine but there are no devices currently available which combine the steps of urine collection, fixation and filtering in a single easy-to-use apparatus. Significant advances are being made in the understanding of tumor pathology of urinary carcinogenesis. For example, cancer diagnostic methods relying on the application of biomarkers to cells are becoming increasingly sophisticated. The measurement of such biomarkers in urine cells requires a prescribed fixation process in order to preserve the reactivity of the markers being assessed.
Additionally, there is increasing evidence of the importance of monitoring the protein composition or cellular content in the urine of individuals with occupational nephrotoxic exposure and of organ transplant patients. Kidney tubular cells shed into the urine may be extremely useful for monitoring the subclinical effects of various nephrotoxic agents of renal disease including those in the environment as well as those iatrogenically induced in the hospital situation associated with antibiotic and nephrotoxic chemotherapy.
Organ transplantation rejection may be monitored by collecting urine and quantitating the various types of cells exfoliated into the urine by using antibodies against available proximal, distal and convoluted tubular kidney cells. Hospital inpatients receiving pancreatic implants with small bowel fistulas draining into the bladder may also benefit from monitoring the number of pancreatic cells shed into the urine.
There is also a need for the proper collection and preservation of sputum and colon washings. Colon cytology specimens can be used in conjunction with various types of biomarkers for colon cancer diagnosis.
As the clinical procedures described above become more common and used on a wider scale, improved methods and devices for collecting and properly preparing fluid samples for testing will become paramount.